SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS— 510(k) K033372

Name: FDA 510(k) clearance K033372
Creator: U.S. Food and Drug Administration
Published: 2004-01-09

Substantially Equivalent

Micro Therapeutics, Inc.

FDA 510(k) clearance K033372 for SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS, Substantially Equivalent on 2004-01-09. Applicant: Micro Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Micro Therapeutics, Inc.
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2003-10-22
Decision date: 2004-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HCG

view all

K262419 — MICRUSFRAME (19+ models)2026-08-14
K261772 — Target Xtra Detachable Coil2026-06-24
K260351 — Numen Helia Coil Embolization System; NumenFR Detachment System2026-05-20
K254221 — Optima Coil System (OptiOne Coil System)2026-01-27
K252694 — Target Detachable Coil2025-12-11

More clearances from Micro Therapeutics, Inc.

view all

K113289 — ORION MICRO CATHETER2012-08-01
K113454 — 14 WIRE STANDARD, 14 WIRE LS2012-02-24
K090870 — ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY2009-05-01
K090046 — CONCERTO DETACHABLE COIL SYSTEM2009-02-27
K081465 — AXIUM DETACHABLE COIL SYSTEM2008-08-19

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.